Human Research Standards in Asia Pacific by Country

General

Key Organizations

• National Health and Medical Research Council (NHMRC)
• Australian Research Council (ARC)
• Australian Institute of Aboriginal and Torres Strait Islander Studies (AIATSIS)

Relevant Standards

• National Health and Medical Research Council Act 1992 (2014)
• National Health and Medical Research Regulation 2016
• NHMRC, Ethical guidelines for research with Aboriginal and Torres Strait Islander Peoples (2018)
• NHMRC, Australian Code for the Responsible Conduct of Research (2018)
• NHMRC, National Statement on Ethical Conduct in Human Research, 2007 (updated 2018)
• Australian States and Territories, National Mutual Acceptance of Scientific and Ethical Review of Multi‑Centre Human Research
• AIATSIS Code of Ethics for Aboriginal and Torres Strait Islander Research

Drugs, Biologics, and Devices

Key Organizations

• Therapeutic Goods Administration (TGA)

Relevant Standards

• Therapeutic Goods Act 1989 (2016)
• Therapeutic Goods Regulations 1990 (2016)
• Australian Clinical Trial Handbook (2018)
• Therapeutic Goods Regulations, Statutory Rules No. 394 (1990) (as in force Mar 1, 2024)
• Australian Regulatory Guidelines for Medical Devices (ARGMD) (2011)

Clinical Trial Registries

Key Organizations

• Australian Clinical Trials
• Australian New Zealand Clinical Trials Registry (ANZCTR)

Relevant Standards

• National Statement on Ethical Conduct in Human Research, 3.1.7 (2018)
• Australian Clinical Trials, Resources
• ANZCTR, FAQs

Research Injury

Key Organizations

• Therapeutic Goods Administration (TGA)
• Medicines Australia
• National Health and Medical Research Council (NHMRC)

Relevant Standards

• TGA, Guidance on Good Clinical Practice (CPMP/ICH‑135/95) (2018)
• Medicines Australia, Indemnity & Compensation Guidelines
• NHMRC, National Statement on Ethical Conduct in Human Research, ¶¶5.1.38–5.1.39 (2018)

Social‑Behavioral Research

Key Organizations

• National Health and Medical Research Council (NHMRC)

Relevant Standards

• National Statement on Ethical Conduct in Human Research, Chapter 3.1 (2018)

Privacy/Data Protection

Key Organizations

• Office of the Australian Information Commissioner

Relevant Standards

• Privacy Act 1988 (2016)
• Australian Privacy Principles Guidelines (2019)
• Guidelines under Section 95 of the Privacy Act 1988 (2014)
• Guidelines Approved under Section 95A of the Privacy Act 1988 (2014)
• Privacy Regulation 2013 (2016)
• Guidelines Approved under Section 95AA of the Privacy Act 1988 (2014)
• Privacy in Australian States and Territories

Human Biological Materials

Key Organizations

• National Health and Medical Research Council (NHMRC)
• Therapeutic Goods Administration (TGA)

Relevant Standards

• NHMRC, National Statement on Ethical Conduct in Human Research, Chapter 3.2 (2023)
• TGA, Australian Regulatory Guidelines for Biologicals (2017)

Genetic Research

Key Organizations

• National Health and Medical Research Council (NHMRC)
• Office of the Gene Technology Regulator

Relevant Standards

• Gene Technology Act 2000 (2016)
• Gene Technology Regulations 2001 (2016)
• NHMRC, National Statement on Ethical Conduct in Human Research, Chapter 3.3 (2023)

Embryos, Stem Cells, and Cloning

Key Organizations

• National Health and Medical Research Council (NHMRC)
• Embryo Research Licensing Committee (NHMRC)

Relevant Standards

• Prohibition of Human Cloning for Reproduction Act 2002 (2008)
• Research Involving Human Embryos Act 2002 (2014)
• Research Involving Human Embryos Regulations (2017)
• NHMRC, National Statement on Ethical Conduct in Human Research, Chapter 3.2 (2023)
• NHMRC, Ethical Guidelines on the Use of Assisted Reproductive Technology in Clinical Practice and Research (2017)

General

Key Organizations

• Bangladesh Medical Research Council, National Research Ethics Committee

Relevant Standards

• Ethical Guidelines for Conducting Research Studies Involving Human Subjects
• Standard Operating Procedures (SOPs)

Drugs, Biologics, and Devices

Key Organizations

• Bangladesh Directorate of Drug Administration

Relevant Standards

• The Drugs Act (1964)
• Drugs (Control) Ordinance 1982, Ordinance No. VIII
• Good Clinical Practice (GCP) Guidelines

Human Biological Materials

Key Organizations

• Bangladesh Medical Research Council, National Research Ethics Committee

Relevant Standards

• Guidelines for Transfer of Human Biological Materials Abroad for Research Purposes (2004)

General

Key Organizations

• National Health Commission of the People’s Republic of China (NHC)
• State Administration for Market Regulation
• National Medical Products Administration (NMPA)

Relevant Standards

• Law on Practicing Doctors (1998), Articles 26 and 37
• Human Genetic Resources Management Regulations (2019)
• Guidelines on Ethical Review of Biomedical Research Involving Human Subjects (2016)
• Management Guidelines for Clinical Research at Medical/Health Institutions (2014)

Drugs, Biologics, and Devices

Key Organizations

• National Medical Products Administration

Relevant Standards

• NMPA, Laws and Regulations, various
• NMPA, Regulatory Information, various
• Provisions for Adverse Drug Reaction Reporting and Monitoring, Decree No. 81 (2011)
• Administrative Measures for the Signing and Issuing of Biological Product (2017)
• Guidelines on Ethical Review of Drug Clinical Trials, No. 436 (2010)

Clinical Trial Registries

Key Organizations

• Chinese Clinical Trial Registry (ChiCtr)

Relevant Standards

• ChiCtr, FAQs

Privacy/Data Protection — Mainland

Key Organizations

• Ministry of Industry and Information Technology of PRC
• Office of the Central Cyberspace Affairs Commission
• National Information Security Standardization Technical Committee (TC260)

Relevant Standards

• Cyber Security Law (2016)
• Electronic Commerce Law, Articles 23–25 and 32 (2018)
• Personal Information Security Specification (GB/T 35273‑2017)

Privacy/Data Protection — Hong Kong

Key Organizations

• Privacy Commissioner for Personal Data, Hong Kong
• eHealth Electronic Health Record Sharing System

Relevant Standards

• Personal Data (Privacy) Ordinance (2018)
• Code of Practice on the Identity Card Number and Other Personal Identifiers (2016)
• Ethics Guidelines for Medical and Health Research Involving Human Subjects (context referenced)

Research Injury

Key Organizations

• National Health Commission (NHC)
• National Medical Products Administration (NMPA)

Relevant Standards

• Tort Liability Law of the PRC, Chapter 7 (2009)
• NMPA, Laws and Regulations, various
• NMPA, Regulatory Information, various
• Guidelines on Ethical Review of Biomedical Research Involving Human Subjects (2016), Articles 18.5, 20.8, 36.6, and 37

Genetic Research

Key Organizations

• National Health Commission (NHC)
• Ministry of Science and Technology (MOST)

Relevant Standards

• Human Genetic Resources Management Regulations (2019)
• Service Guidelines for the Collection, Selling, Export, and Admission Application of Human Genetic Resources (2015)

Embryos, Stem Cells, and Cloning — Mainland

Key Organizations

• National Health Commission (NHC)
• Ministry of Science and Technology (MOST)

Relevant Standards

• Ethical Principles and Conduct Norms for Human Assisted Reproductive Technologies (2003)
• Administrative Measures for Clinical Application of Medical Technology (2018)
• Interim Measures for Stem Cell Clinical Research (2015)
• Ethical Guidelines for Research on Human Embryo Stem Cells (2003)
• Interim Guidelines for Quality Control of Stem Cell Preparations and Preclinical Research (2015)

Embryos, Stem Cells, and Cloning — Hong Kong

Key Organizations

• Legislative Council of the HKSAR

Relevant Standards

• Human Reproductive Technology (Amendment) Ordinance 2016

General

Key Organizations

• Indian Council of Medical Research (ICMR)
• Department of Health Research (DHR)

Relevant Standards

• ICMR Guidelines, various (Ethics)
• National Guidelines for Ethics Committees Reviewing Biomedical and Health Research During COVID‑19
• DHR, National Ethics Committee Registry for Biomedical and Health Research

Drugs, Biologics, and Devices

Key Organizations

• Central Drugs Standard Control Organization (CDSCO), Office of Drugs Controller General of India (DCGI)
• Indian Council of Medical Research (ICMR)

Relevant Standards — Drugs

• Drugs and Cosmetics Act (1940; amended to Dec 31, 2016)
• New Drugs and Clinical Trials Rules (2019)
• CDSCO, Good Clinical Practice Guidelines (2001)
• ICMR Guidelines for Good Clinical Laboratory Practices (GCLP) (2021)

Relevant Standards — Devices

• Medical Devices Rules, 2017 (GSR 78(E))
• ICMR, National Ethical Guidelines (2017), Section 7.7

Clinical Trial Registries

Key Organizations

• Indian Council of Medical Research (ICMR)

Relevant Standards

• Clinical Trials Registry – India
• CTRI, FAQs

Research Injury

Key Organizations

• Central Drugs Standard Control Organization (CDSCO)
• Indian Council of Medical Research (ICMR)

Relevant Standards

• New Drugs and Clinical Trials Rules (2019)
• ICMR, National Ethical Guidelines (2017), Section 2.6

Social‑Behavioral Research

Key Organizations

• Indian Council of Medical Research (ICMR)

Relevant Standards

• National Ethical Guidelines (2017), Section 9

Privacy/Data Protection

Key Organizations

• Indian Council of Medical Research (ICMR)
• National AIDS Control Organization (NACO)
• Ministry of Electronics & Information Technology (MeitY)
• National Health Authority (NHA)

Relevant Standards

• ICMR, National Ethical Guidelines (2017)
• NACO, Data Protection Guidelines
• Digital Personal Data Protection Act (2023)
• National Digital Health Mission, Health Data Management Policy
• Ethical Guidelines for AI in Biomedical Research and Healthcare (2023)

Human Biological Materials

Key Organizations

• Indian Council of Medical Research (ICMR)
• Central Drugs Standards Control Organization (CDSCO)

Relevant Standards

• Govt. of India Office Memorandum (O.M. No.19015/53/1997‑IH Pt.) 19 Nov 1997 on Exchange of Human Biological Material for Biomedical Research Purposes
• National Ethical Guidelines (2017), Section 11

Genetic Research

Key Organizations

• Department of Biotechnology (DBT)
• Indian Council of Medical Research (ICMR)
• Central Drugs Standards Control Organization (CDSCO)

Relevant Standards

• DBT, Environmental Protection Act (1986)
• DBT, Recombinant DNA Safety Guidelines (1990)
• Regulations and Guidelines for Recombinant DNA Research and Biocontainment (2017)
• DBT, Ethical Policies on the Human Genome, Genetic Research, and Services (2002)
• ICMR, National Ethical Guidelines (2017), Section 10
• National Guidelines for Gene Therapy Product Development and Clinical Trials (2019)

Embryos, Stem Cells, and Cloning

Key Organizations

• Indian Council of Medical Research (ICMR)
• Department of Biotechnology (DBT)
• Central Drugs Standard Control Organization (CDSCO)
• Department of Health Research (DHR)

Relevant Standards

• National Guidelines for Stem Cell Research (2017)
• DBT Biosafety Programme: Guidelines, Rules, and Regulations
• CDSCO, Stem Cell and Cell‑based Products
• Surrogacy (Regulation) Act (2021)
• Surrogacy Regulation Rules (2022)
• National Guidelines for Hematopoietic Cell Transplantation (2021)
• Assisted Reproductive Technology (Regulation) Act
• ART Regulations Rules (2022)
• Guidelines for Umbilical Cord Blood Banking

General

Key Organizations

• Ministry of Health, National Institute of Health Research and Development

Relevant Standards

• Indonesian Health Act No. 23/1992, Article 69
• Regulation No. 39/1995 on Health Research and Development
• Presidential Decree No. 100/1993: Research by Foreigners
• National Guidelines on Ethics in Health Research (2003)

Drugs, Biologics, and Devices

Key Organizations

• National Agency of Drug and Food Control

Relevant Standards

• Ministry of Health Decree No. 56/2000: Guidelines on Clinical Trials of Traditional Drugs
• Guidelines on Good Clinical Practice (2001)

Human Biological Materials

Relevant Standards

• National Guidelines on Use of Stored Biological Materials (2005)

General

Key Organizations

• Ministry of Education, Culture, Sports, Science, and Technology (MEXT)
• Ministry of Health, Labor, and Welfare (MHLW)

Relevant Standards

• Ethical Guidelines for Medical and Biological Research Involving Human Subjects (2021)
• Clinical Trials Act (2009)

Drugs, Biologics, and Devices

Key Organizations

• Ministry of Health, Labor, and Welfare (MHLW)
• Pharmaceuticals and Medical Devices Agency (PMDA)

Relevant Standards

• Pharmaceuticals, Medical Devices, and Other Therapeutic Products Act (2016)
• Clinical Trials Act (2017)
• Ministerial Ordinance on Good Clinical Practice for Drugs (2020)

Clinical Trial Registries

Key Organizations

• MHLW
• National Institute of Public Health (NIPH)
• Japan Registry of Clinical Trials (jRCT)

Relevant Standards

• Clinical Trials Act (2017)
• NIPH Clinical Trials Search

Research Injury

Key Organizations

• MHLW

Relevant Standards

• Pharmaceuticals, Medical Devices, and Other Therapeutic Products Act (2016)
• Clinical Trials Act (2017)
• Ministerial Ordinance on GCP for Drugs (2020), Article 14, 23
• Ethics Guidelines for Medical and Health Research Involving Human Subjects (2021): Chapters 2, 3, and No. 6

Privacy/Data Protection

Key Organizations

• Personal Information Protection Commission (PPC)
• Office of Healthcare Policy of the Cabinet Secretariat

Relevant Standards

• Act on the Protection of Personal Information (2020)
• Act on the Protection of Personal Information, various laws and policies
• Act Regarding Anonymized Medical Data for R&D in the Medical Field (2017)
• Amendment to the Cabinet Order to Enforce APPI (2016)
• Enforcement Rules for APPI (2016)
• Regulation for Enforcement of the Clinical Trials Act, Article 20 (2018)

Human Biological Materials

Key Organizations

• MHLW

Relevant Standards

• On Research and Development Utilizing Human Tissues Removed for Surgery and Other Procedures (1998)

Genetic Research

Key Organizations

• Council for Science, Technology, and Innovation (CSTI)
• MEXT
• MHLW
• METI

Relevant Standards

• Ethical Guidelines for Medical and Biological Research Involving Human Subjects (2021)
• Fundamental Principles of Research on the Human Genome (2000)
• Ethics Guidelines for Human Genome/Gene Analysis Research (2017)
• Guidelines for Clinical Research in Gene Therapy and Others (2019)
• Genetic recombination experiments
• Genome editing technology

Embryos, Stem Cells, and Cloning

Key Organizations

• CSTI
• MEXT
• MHLW

Relevant Standards

• Act on Regulation of Human Cloning Techniques (English ver. 2000; amended 2014)
• Ordinance for Enforcement of Act on Regulation of Human Cloning Techniques (2021)
• Act on Safety of Regenerative Medicine (2013)
• Ordinance for Enforcement of Act on Safety of Regenerative Medicine (2019)
• Rules for Enforcement of Act on Safety of Regenerative Medicine (2018)
• Guidelines on the Distribution of Human Embryonic Stem Cells (2019)
• Guidelines on the Utilization of Human Embryonic Stem Cells (2019)
• Guidelines on Research on Producing Germ Cells from Human iPSCs or Tissue Stem Cells (2015)
• English version (2010)
• Fundamental Philosophy on Handling of Human Embryo (2004)
• Guidelines on the Handling of a Specified Embryo (2021)
• Ethical Guidelines for Research on Assisted Reproductive Technology to Develop Human Fertilized Embryos (2021)
• Guidelines for Research Using Gene‑altering Technologies on Human Fertilized Embryos (2021)

General

Key Organizations

• Ministry of Healthcare and Social Development, Central Commission on Research Ethics

Relevant Standards

• Guidelines on Ethics in Health Research (2007)
• Local Ethics Committees: Policy, Rules, and Procedures (2014)
• Guidelines on Ethics in Biomedical Research (2015)

Drugs, Biologics, and Devices

Key Organizations

• Committee for Medical and Pharmaceutical Control

Relevant Standards

• Code of the Republic of Kazakhstan "On People's Health and the Health Care System" (2009/2015), Articles 74 and 180
• Order No. 697 (2009) Medical‑Biological Experiments; Preclinical & Clinical Trials
• Order No. 744 (2009) Conduct of Clinical Trials of Pharmaceutical & Drug Products, Medical Devices, and Equipment
• Order No. 272 (2014) Implementation of New Methods of Diagnosis, Treatment, and Rehabilitation
• Guidelines on Clinical Trials in Kazakhstan (2003)

Privacy/Data Protection

Key Organizations

• Ministry of Healthcare and Social Development

Relevant Standards

• Code of the Republic of Kazakhstan “On People's Health and the Health Care System,” Article 28 (2015)

General

Key Organizations

• Ministry of Health
• Ministry of Justice of the Kyrgyz Republic

Relevant Standards

• Constitution of Kyrgyz Republic, Chapter II, Article 22 (2010)
• Law on Health Protection (2005), Articles 34 and 72
• Code of Professional Ethics of Medical Worker (2004)
• Code of Administrative Responsibility No. 114 (1998; updates 2008)

Drugs, Biologics, and Devices

Key Organizations

• Department of Drugs and Medical Devices (DDMD)
• National Bioethics Committee
• Pharmaceutical Union of Kyrgyzstan, Ethics Committee

Relevant Standards

• Law on the Circulation of Medicinal Products (as amended 2018), Chapter VII, Articles 24–25
• National Standard KMC 1195:2010: Medical Devices — Rules for Clinical Trials (2010)
• Technical Regulations on Safety of Medical Products for Medical Application (Gov’t Order #74, 2012)

Research Injury

Key Organizations

• Department of Drug and Medical Devices Provision (DDMDP)
• National Bioethics Committee

Relevant Standards

• Law on the Circulation of Medicinal Products, Chapter VII, Articles 24–25
• National Standard KMC 1195:2010 — paragraphs 3, 4, and 6

Human Biological Materials

Key Organizations

• DDMDP
• National Bioethics Committee

Relevant Standards

• Law on Health Protection (2005), Article 39
• Technical Regulations on Safety of Medical Products (Gov’t Order #74, 2012)

Social‑Behavioral Research

Key Organizations

• Ministry of Justice of the Kyrgyz Republic

Relevant Standards

• Law On the Protection of Traditional Knowledge (as amended 2014)

Privacy/Data Protection

Key Organizations

• DDMDP
• National Bioethics Committee

Relevant Standards

• Law on Health Protection (2005), Article 91
• National Standard KMC 1195:2010 — paragraphs 3, 4, and 6
• Technical Regulations on Safety of Medical Products (Gov’t Order #74, 2012)

General

Key Organizations

• Ministry of Health, National Institutes of Health (NIH)
• Academy of Sciences Malaysia (ASM)

Relevant Standards

• Malaysian Guidelines of Good Clinical Practice (2020)
• Medical Review and Ethics Committee (MREC) Guideline (2021)
• The Malaysian Code of Responsible Conduct in Research (2020)
• Clinical Trials and Biomedical Research (2007)
• Malaysian Guideline for Application of Clinical Trial Import License and Clinical Trial Exemption, 7th/8th Edition

Drugs, Biologics, and Devices

Key Organizations

• National Pharmaceutical Regulatory Agency (NPRA)
• National Committee for Clinical Research (NCCR)
• Medical Device Authority (MDA)
• Clinical Research Malaysia (CRM)

Relevant Standards

• NPRA, Various Directives
• NPRA, Malaysian Guidelines of Good Clinical Practice, 4th Ed (2018)
• NPRA, GCP Inspection, Edition 2.1 (2020)
• NPRA, Phase I Unit Inspection & Accreditation Program (2018)
• NPRA, FAQ: Clinical Trials – Safety Reporting (Updated Apr 18, 2024)
• NCCR, Various Guidelines
• CRM, Guidelines & Circulars, various
• MDA, Various Legislations
• MDA, Circular Letters
• MDA, Guidance Documents under Medical Device Act (2012)

Clinical Trial Registries

Key Organizations

• National Medical Research Register (NMRR)

Relevant Standards

• NMRR, User Manual
• NMRR, Guidelines, various

Research Injury

Key Organizations

• NPRA
• Department of Occupational Safety and Health (DOSH)

Relevant Standards

• Occupational Safety and Health Act 1994: Section 32
• NPRA, Malaysian Guidelines of Good Clinical Practice, 4th Ed (2018)

Social‑Behavioral Research

Key Organizations

• Academy of Sciences Malaysia (ASM)
• Institute for Health Behavioural Research (IPTK)

Relevant Standards

• Malaysian Code of Responsible Conduct in Research (2020)

Privacy/Data Protection

Key Organizations

• Department of Personal Data Protection

Relevant Standards

• Act 709: Personal Data Protection Act (2010)

Human Biological Materials

Key Organizations

• National Committee for Clinical Research (NCCR)

Relevant Standards

• Act 130, Human Tissues Act (1974)
• Act 699, DNA Identification Act 2009
• Act 795 Access to Biological Resources and Benefit Sharing Act (2017)
• User’s Guide to Act 795 (2017)
• Malaysian Guideline on the Use of Human Biological Sample for Research (2015)

Genetic Research

Key Organizations

• Medical Development Division, MOH
• Ministry of Energy and Natural Resources
• University of Malaysia

Relevant Standards

• Biosafety Act 2007 (Act 678)
• Biosafety (Approval and Notification) Regulations 2010
• MMC, Medical Genetics and Genetic Services — MMC Guidelines 010/2006
• Guidelines for Institutional Biosafety Committees (2010)
• MOH, Guidelines on Ethical Issues in Medical Genetics Services (2019)
• Act 795 Access to Biological Resources and Benefit Sharing Act (2017)
• User’s Guide to Act 795

Embryos, Stem Cells, and Cloning

Key Organizations

• NPRA
• NIH
• National Pharmaceutical Control Bureau (NPCB)
• Medical Development Division, MOH
• Malaysian Medical Council (MMC)
• Malaysian Society of Transplantation (MST)

Relevant Standards

• NIH, Checklist for Research on Stem Cell and Cell‑Based Therapies (2015)
• NPRA, Guidance for Registration of Cell and Gene Therapy Products (2016)
• MOH, Guidelines for Stem Cell Research and Gene Therapy (2009)
• National Organ, Tissue and Cell Transplantation Policy
• MOH, National Standards for Cord Blood Banking and Transplantation
• MOH, National Standards For Stem Cell Transplantation (2nd ed., 2018)
• MOH, National Guidelines For Haemopoietic Stem Cell Therapy (2009)
• MMC, Stem Cell Research and Stem Cell Therapy, Guideline 002/2009

General

Key Organizations

• Department of Medical Research (DMR), Ministry of Health
• Ministry of Health National Ethics Committee on Clinical Research

Relevant Standards

• DMR, Guideline for Submission to Ethics Review Committee (2016)

Drugs, Biologics, and Devices

Key Organizations

• Food and Drug Administration (FDA), Ministry of Health

Relevant Standards

• National Drug Law (1992)
• FDA, Various Drug Regulations
• FDA, Various Drug Guidelines
• FDA, Various Medical Device Regulations
• FDA, Various Medical Device Guidelines

Human Biological Materials

Relevant Standards

• Blood and Blood Products Law (2003)
• Body Organ Donation Law (2004)
• Organ Donation Law (Law No. 58/2015) (Burmese)

General

Key Organizations

• Nepal Health Research Council, Ethical Review Board

Relevant Standards

• NHRC, Acts, various
• NHRC, Guidelines, various
• NHRC, Policies, various

Drugs, Biologics, and Devices

Key Organizations

• Nepal Health Research Council

Relevant Standards

• NHRC, Acts, various
• NHRC, Guidelines, various
• NHRC, Policies, various

General

Key Organizations

• Health Research Council (HRC) Ethics Committee
• National Ethics Advisory Committee (NEAC)
• Ministry of Health (MOH)
• Health and Disability Commissioner (HDC)
• Health and Disability Ethics Committees
• Ministry of Business, Innovation and Employment (MBIE)

Relevant Standards

• Health Research Council Act 1990, Sections 24 and 25
• New Zealand Bill of Rights Act, Article 10 (1990)
• Health and Disability Commissioner Act 1994
• New Zealand Public Health and Disability Act 2000, Section 16
• Accident Compensation Act 2001
• HDC, Code of Health and Disability Services Consumers’ Rights (2004)
• HRC, The Role of Ethics — various
• NEAC, National Ethical Standards, various
• NEAC, Publications and Resources, various
• MOH, Standard Operating Procedures for Health and Disability Ethics Committees (2012)

Drugs, Biologics, and Devices

Key Organizations

• Medsafe
• Medicines New Zealand
• HRC Standing Committee on Therapeutic Trials (SCOTT)

Relevant Standards — Drugs

• Accident Compensation Act 2001, Section 32 (2010)
• Medicines Act 1981 (2012)
• Medicines Regulations 1984
• Medsafe, Good Clinical Research Practice & Obtaining Approval for Clinical Trials (2013)
• Medicines NZ, Guidelines on Clinical Trials — Compensation for Injury (2015)

Relevant Standards — Devices

• Medicines (Database of Medical Devices) Regulations (2003)
• SOPs for HDEC (2012)
• Conducting Medical Device Clinical Trials in New Zealand, various

Clinical Trial Registries

Key Organizations

• Australian New Zealand Clinical Trials Registry

Relevant Standards

• ANZCTR, FAQs

Privacy/Data Protection

Key Organizations

• Privacy Commissioner

Relevant Standards

• Official Information Act 1982 (2012)
• Public Records Act (2005)
• Privacy Act 1993 (2012)
• Health Information Privacy Code 1994

Human Biological Materials

Key Organizations

• Ministry of Health
• HRC Ethics Committee
• Te Puni Kōkiri (TPK)
• Office of the Health and Disability Commissioner (HDC)
• MBIE

Relevant Standards

• Health Act 1956 (2012)
• Human Tissue Act 2008
• MOH, Guidelines for Use of Human Tissue for Future Unspecified Research (2007)

Genetic Research

Key Organizations

• Environmental Protection Authority
• HRC Gene Technology Advisory Committee (GTAC)

Relevant Standards

• Hazardous Substances and New Organisms Act 1996 (2012)

Embryos, Stem Cells, and Cloning

Key Organizations

• Advisory Committee on Assisted Reproductive Technology (ACART)
• Ethics Committee on Assisted Reproductive Technology (ECART)
• Ministry of Health

Relevant Standards

• Human Assisted Reproductive Technology Act 2004 (2009)
• HART Order (2005)
• ACART, Publications and Resources, various

General

Key Organizations

• National Bioethics Committee

Relevant Standards

• National Bioethics Committee, Various Guidelines
• National Bioethics Committee, Various Downloads

Drugs, Biologics, and Devices

Key Organizations

• National Bioethics Committee

Relevant Standards

• Guidelines For Healthcare Professionals Interaction with Pharmaceutical Trade and Industry (PPI Guidelines)

Human Biological Materials

Key Organizations

• National Bioethics Committee

Relevant Standards

• National Guidelines for Collection, Usage, Storage, and Export of Human Biological Materials (2020)
• Ethical Guidelines for Collection, Usage, Storage, and Export of Human Biological Materials (2016)

Embryos, Stem Cells, and Cloning

Key Organizations

• National Bioethics Committee

Relevant Standards

• Protocol/Guidelines for Stem Cell Research/Regulation in Pakistan

General

Key Organizations

• Philippine Health Research Ethics Board (PHREB)
• Department of Science and Technology (DOST)
• Department of Health (DOH)
• Commission of Higher Education (CHED)
• National Commission on Indigenous Peoples (NCIP)

Relevant Standards

• Republic Act No. 10532 (PNHRS Act) (2013)
• PNHRS Implementing Rules and Regulations
• PHREB National Ethical Guidelines (2017)
• PHREB, Orders and Memoranda, various
• Memorandum: Registration & Accreditation of all Ethics Review Committees (2015)

Drugs, Biologics, and Devices

Key Organizations

• Food and Drug Administration (FDA)

Relevant Standards

• Administrative Order No. 47‑a (2001) — Vaccines & Biologic Products
• FDA, Guidelines: Regulation of Clinical Trials in the Philippines
• FDA, Circular 2015‑026 — Adoption of ICH Q5C
• PHREB, Orders and Memoranda
• PHREB National Ethical Guidelines (2017), p.70

Clinical Trial Registries

Key Organizations

• Philippine Health Research Registry

Relevant Standards

• PHREB National Ethical Guidelines

Research Injury

Key Organizations

• DOST
• PHREB

Relevant Standards

• PHREB National Ethical Guidelines

Social‑Behavioral Research

Key Organizations

• PHREB
• Philippine Social Science Council (PSSC)

Relevant Standards

• National Ethical Guidelines (2017), pp.108–118

Privacy/Data Protection

Relevant Standards

• Republic Act No. 10173: Data Privacy Act of 2012
• Data Privacy Act Implementing Rules and Regulations (2016)

Embryos, Stem Cells, and Cloning

Key Organizations

• PHREB

Relevant Standards

• National Ethical Guidelines (2017), pp. 91, 157, 163

General

Key Organizations

• Ministry of Health (MOH)
• Bioethics Advisory Committee (BAC)

Relevant Standards

• Human Biomedical Research Act 2015
• Human Biomedical Research Regulations 2017
• MOH Resources on HBRA
• Ethics Guidelines for Human Biomedical Research (2015)

Drugs, Biologics, and Devices

Key Organizations

• Health Sciences Authority (HSA)
• MOH
• NEA, Centre For Radiation Protection And Nuclear Science

Relevant Standards

• Health Products Act 2007
• Medicines Act 1975
• Health Products (Clinical Trials) Regulations 2016
• Health Products (Therapeutic Products as Clinical Research Materials) Regulations 2016
• Medicines (Clinical Trials) Regulations 2016
• Medicines (Medicinal Products as Clinical Research Materials) Regulations 2016
• Singapore Guidance on GCP Compliance Inspection (2021)
• ICH E6(R2) Good Clinical Practice Guideline (2016)
• Health Products (Medical Device) Regulations 2010
• Radiation Protection Act 2007
• Radiation Protection (Non‑Ionising Radiation) Regulations 1991
• HSA, Clinical Trials — Overview
• HSA, Guidance Documents for Clinical Trials
• HSA, Clinical Trials of Medical Devices

Research Injury

Key Organizations

• MOH
• HSA

Relevant Standards

• Human Biomedical Research Act 2015
• Health Products Act (Cap 122D)
• Human Biomedical Research Regulations 2017
• Health Products (Clinical Trials) Regulations 2016
• Medicines (Clinical Trials) Regulations (2016)
• Singapore Guideline for GCP (2016)

Privacy/Data Protection

Key Organizations

• MOH
• Personal Data Protection Commission (PDPC)
• Bioethics Advisory Committee (BAC)

Relevant Standards

• Personal Data Protection Act 2012
• PDPC Advisory Guidelines for the Healthcare Sector
• Personal Information in Biomedical Research (2007)

Human Biological Materials

Key Organizations

• MOH
• BAC

Relevant Standards

• Medical (Therapy, Education, and Research) Act 1972
• Human Biomedical Research (Tissue Banking) Regulations 2019
• Guidance on Prohibition against Commercial Trading of Human Tissue (2017)
• Guide on Appropriate Consent for HBR & Handling of Human Tissue (2019)
• BAC, Human Tissue Research (2002)
• Directive on Use of In‑House Cell, Tissue and Gene Therapy Products (2020)

Genetic Research

Key Organizations

• BAC

Relevant Standards

• Genetic Testing and Genetic Research (2005)
• Directive on Use of In‑House Cell, Tissue and Gene Therapy Products (2020)

Embryos, Stem Cells, and Cloning

Key Organizations

• MOH
• BAC

Relevant Standards

• Human Cloning and Other Prohibited Practices Act 2004
• Human Biomedical Research (Restricted Research) Regulations 2017
• Ethical, Legal and Social Issues in Human Stem Cell Research (2002)
• Donation of Human Eggs for Research (2008)
• Human‑Animal Combinations in Stem‑Cell Research (2010)

General

Key Organizations

• Ministry of Health and Welfare (MOHW)

Relevant Standards

• Bioethics and Safety Act No. 16372 (2019)
• Enforcement Decree No. 30141 (2019)
• Enforcement Rule No. 733 (2020)

Drugs, Biologics, and Devices

Key Organizations

• Ministry of Food and Drug Safety (MFDS)

Relevant Standards

• Pharmaceutical Affairs Act No. 16250 (2019)
• Medical Device Act No. 16402 (2019)
• Act on In Vitro Diagnostic Medical Devices No. 16433 (2019)
• Regulation on Approval for Investigational Device Exemption (2019‑33)
• Regulation on Approval for Investigational New Drug Application (2021‑12)
• Enforcement Decree of the Medical Device Act No. 1580 (2019)
• Regulation on Safety of Medicinal Products No. 1576 (2019)

Clinical Trial Registries

Key Organizations

• Clinical Research Information Service (CRIS)
• MFDS, Clinical Trial Search

Relevant Standards

• MFDS, Laws/Decrees/Rules
• Regulation on Safety of Medicinal Products No. 1576 (2019)

Research Injury

Key Organizations

• MFDS

Relevant Standards

• Pharmaceutical Affairs Act No. 16250 (2019)
• Regulation on Safety of Pharmaceuticals, etc. No. 1576 (2019)
• Enforcement Rule of the Medical Devices Act No. 1580 (2019; amended 2021)
• Guidelines for Clinical Trial Indemnity and Its Process (2021)
• Guidance for Sponsors; Safety Reporting Requirements (2020)

Social‑Behavioral Research

Key Organizations

• MOHW
• Ministry of the Interior and Safety

Relevant Standards

• Bioethics and Safety Act No. 16372 (2019)
• Enforcement Decree No. 30141 (2019)
• Enforcement Rule No. 733 (2020)
• Personal Information Protection Act No. 16930 (2020)
• Enforcement Decree of PIPA No. 30892 (2020)

Privacy/Data Protection

Key Organizations

• MOIS
• MOHW
• Personal Information Protection Commission (PIPC)

Relevant Standards

• Personal Information Protection Act No. 16930 (2020)
• Enforcement Decree No. 30892 (2020)
• Bioethics and Safety Act No. 16372 (2019)
• Act on Dissection and Preservation of Corpses No. 17472 (2021)
• Guidelines for the Use of Health and Medical Data (2021)
• Standard Personal Information Protection Guidelines (2020)
• Guidelines for the Pseudonymisation of Personal Information (2020)

Human Biological Materials

Key Organizations

• MOHW
• MFDS

Relevant Standards

• Bioethics and Safety Act No. 16372 (2019; amended 2020)
• Enforcement Rule No. 733 (2020)
• Enforcement Decree of Pharmaceutical Affairs Act No. 30141 (2019)
• Guidelines on Biological Material Management in Clinical Trial (2018)

Genetic Research

Key Organizations

• MOHW
• MFDS

Relevant Standards

• Bioethics and Safety Act No. 16372 (2019)
• Enforcement Decree No. 30141 (2019)
• Enforcement Rule No. 733 (2020)

Embryos, Stem Cells, and Cloning

Key Organizations

• MOHW
• MFDS

Relevant Standards

• Bioethics and Safety Act No. 16372 (2019)
• Enforcement Decree No. 30141 (2019)
• Enforcement Rule of the Safety and Support of Advanced Regenerative Medicine No. 746 (2020)
• Enforcement Decree of Advanced Regenerative Medicine and Advanced Biopharmaceuticals Safety and Support Act No. 30979 (2020)
• Enforcement Rule of Advanced Biopharmaceuticals Safety and Support No. 1641 (2020)
• Guideline on Quality Assessment for Gene‑Editing Based Advanced Therapy Medicinal Products (2018)

Drugs, Biologics, and Devices

Key Organizations

• Cosmetics, Devices, and Drugs Regulatory Authority (website under construction; interim info via NMRA site)

Clinical Trial Registries

Key Organizations

• Sri Lanka Clinical Trials Registry

Relevant Standards

• SLCTR FAQs

General

Key Organizations

• Ministry of Health and Welfare (MOHW)

Relevant Standards

• Human Subjects Research Act (2019) (Chinese)
• Medical Care Act (2018)
• Regulations on Human Trials (2016)
• Enforcement Rules of the Medical Care Act (2017) (Chinese)
• Regulations for Organization & Operation of HRE Review Boards (2018)
• Exempt Review Categories for Human Research (2012)
• Informed Consent Exemptions for Human Research (2012)
• Expedited Review Categories for Human Research (2012)

Drugs, Biologics, and Devices

Key Organizations

• MOHW
• Taiwan Food and Drug Administration (FDA)

Relevant Standards

• Medical Care Act (2018)
• Pharmaceutical Affairs Act (2018)
• Regulations on Human Trials (2016)
• Pharmaceutical Affairs Act Enforcement Rules (2016)
• Regulations for Drug Safety Monitoring (2013)
• Regulations for Good Clinical Practice (2014)
• Regulations for Management of Medical Devices (2014)
• Regulation on Bioavailability and Bioequivalence Studies (2015)

Research Injury

Key Organizations

• MOHW
• FDA (MOHW)

Relevant Standards

• Medical Care Act (2018)
• Regulation for Good Clinical Practice (2014)

Social‑Behavioral Research

Key Organizations

• MOHW

Relevant Standards

• Exempt Review Categories for Human Research (2012)

Privacy/Data Protection

Key Organizations

• Ministry of Justice

Relevant Standards

• Personal Information Protection Act (2015)
• Enforcement Rules of the Personal Data Protection Act (2016)

Human Biological Materials

Key Organizations

• MOHW

Relevant Standards

• Human Biobank Management Act (2012)
• Medical Care Act (2018)
• Regulations on Human Trials (2009)
• Administrative Regulations on the Establishment of Human Biobanks (2011)

Genetic Research

Key Organizations

• MOHW
• FDA
• Ministry of Science and Technology (NSTC)

Relevant Standards

• Human Biobank Management Act
• Regulations on Commercial Benefit Feedback of Human Biobanks (2010)
• Administrative Regulations on Establishment of Human Biobanks (2011)
• Guidance for Information Safety of Human Biobank (2010) (Chinese)

Embryos, Stem Cells, and Cloning

Key Organizations

• MOHW

Relevant Standards

• Artificial Reproduction Act (2018)

General

Key Organizations

• Ministry of Public Health

Relevant Standards

• Order of the Ministry of Public Health (10 March 2005 No. 118) — Normative Documents of Republic Committee on Medical Ethics

General

Key Organizations

• National Research Council of Thailand (NCRT)
• Medical Council of Thailand (MCT)
• Forum for Ethical Review Committees in Thailand (FERCIT)

Relevant Standards

• NCRT, Initial Registration of an REC‑EC‑IRB (2022)
• NCRT, National Policy and Guidelines for Human Research (2015)
• MCT, Various Acts and Rules
• NCRT, Regulation on the Permission of Foreign Researchers (1982)
• NCRT, Guidance for Foreign Researchers, various
• FERCIT, Ethical Guidelines for Research on Human Subjects in Thailand (2007)

Drugs, Biologics, and Devices

Key Organizations

• Food and Drug Administration
• Medical Council of Thailand (MCT)

Relevant Standards

• FDA, Laws and Regulations — Medicines
• FDA, Laws and Regulations — Devices
• Consumer Protection Act (2007)
• FDA, Rules on Accepting Ethics Committees for Human Subjects Research (2018)
• MCT, Acts and Rules, various
• MCT, Thailand Good Clinical Practice Guidelines (2002)
• Medical Device Act (1988)

Clinical Trial Registries

Key Organizations

• Thai Clinical Trials Registry

Relevant Standards

• TCTR FAQs

Privacy/Data Protection

Key Organizations

• Office of the Information Commission

Relevant Standards

• Official Information Act, B.E. 2540 (1997)
• Ministerial Regulations, various

General

Key Organizations

• Government of the Republic of Uzbekistan
• Ministry of Health

Relevant Standards

• Constitution of Republic of Uzbekistan, Articles 24, 26, 40, 44 (1992)
• Law on Protection of Citizens’ Health (1997)

Drugs, Biologics, and Devices

Key Organizations

• Center for Pharmaceutical Products Safety
• Scientific Boards of Medical Institutes

Relevant Standards

• Center for Pharmaceutical Products Safety, Documents (laws, decrees, standards)
• Law on Protection of Citizens’ Health (1997)
• Law on Drugs and Pharmaceutical Activity (1997)
• Law on Narcotic and Psychoactive Drugs (2000)
• Guidelines on Conducting Clinical Trials and Determining Clinical Sites (2001)
• National Standard of Uzbekistan: Good Clinical Practice (2013)

Human Biological Materials

Key Organizations

• Pharmacological Committee (MOH), Central Dept. for Quality Control
• National Ethics Committee
• Scientific Boards of Medical Institutes

Relevant Standards

• Guidelines on Conducting Clinical Trials and Determining Clinical Sites (2001)
• National Standard of Uzbekistan: Good Clinical Practice (2013)

General

Key Organizations

• Ministry of Health (MOH)

Relevant Standards

• Decision No. 111/QD‑BYT (2013): Council of Ethics in Biomedical Research — Organization & Operation
• Decision No. 460/QD‑BYT (2012): Ethical Evaluation Committee — Organization & Operation
• Circular No. 45/2017/TT‑BYT (Vietnamese): Ethics Committee — Establishment & Powers
• Decision No. 1122/QD‑BYT (2018): Establishment of MOH Ethics Committee (2018–2023)

Drugs, Biologics, and Devices

Key Organizations

• Ministry of Health

Relevant Standards

• Law on Pharmacy (No. 34/2005/QH11) (2005) — selected articles
• Decision No. 799/QD‑BYT (2008): Guideline on Good Clinical Practice — Chapter III
• Circular — Guidelines for Clinical Trials on Drugs (2012)
• Circular No. 29/2018/TT‑BYT: Clinical Trials on Drugs (Vietnamese)